Search Results

The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with Effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Tonsillectomy
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The Wands are bipolar, single use, high frequency electrosurgical devices designed for a variety of ENT applications.

The provided document is a 510(k) summary for a medical device (ENTec® Plasma Wands) that refers to a modification in labeling for a previously cleared device. It explicitly states that the "indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s."

This type of submission (a Special 510(k)) does not typically involve new clinical studies to demonstrate device performance against acceptance criteria. Instead, it relies on demonstrating that the proposed changes do not significantly affect the safety or efficacy of the device, often by showing equivalence to a predicate device.

Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert ground truth, etc., for proving device performance for this particular 510(k) submission (K021364) is not applicable because a new performance study was not conducted or reported in this document. The submission is a "labeling modification" for an already cleared device.

The document states:

• "This Special 510(k) proposes a modification in labeling for the Wands, which were previously cleared under K014290 on March 28, 2002."
• "The indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s."
• "The proposed modification in labeling is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

In summary, based on the provided text, there is no information about new acceptance criteria, a study proving performance, sample sizes, expert ground truth, or MRMC/standalone studies because this 510(k) is for a labeling modification of an already cleared device, not for a new device requiring primary performance validation.

Ask a specific question about this device

The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with Effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Tonsillectomy
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The ENTec Plasma Wands are bipolar, high frequency electrosurgical devices designed to be used in conjunction with the ENTec Coblator Plasma Surgery System.

This document is a 510(k) summary for the ArthroCare ENTec® Plasma Wands™, submitted to the FDA for market clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific device performance from a study, sample sizes, expert involvement, and ground truth methodologies is not explicitly available within the provided text. The document is a regulatory submission for premarket clearance, not a clinical study report.

Here's an attempt to answer the questions based only on the provided text, while also clearly stating what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for use (which are essentially the same as the predicate devices).
• Materials incorporated.
• Product specifications.
• Energy requirements.

No specific quantitative acceptance criteria (e.g., minimum ablation rate, maximum tissue damage at a certain power) or a study reporting detailed device performance against such criteria are presented. The core argument is that the device is similar enough to already approved devices.

2. Sample size used for the test set and the data provenance

This information is not provided in the 510(k) summary. Given that it's a 510(k) for substantial equivalence and not a clinical trial report, there's no mention of a "test set" in the context of clinical performance data. The evaluation was likely based on bench testing, comparison of specifications, and a review of existing clinical data for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. There is no mention of a "test set" requiring expert ground truth in this document.

4. Adjudication method for the test set

This information is not provided. There is no mention of a "test set" or an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI performance evaluation is irrelevant and not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. This is an electrosurgical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. No specific "ground truth" (in the context of clinical outcomes or diagnostic accuracy) is discussed as this is a 510(k) for an electrosurgical device based on substantial equivalence. The "ground truth" for the submission is that the predicate devices are safe and effective, and the new device is substantially equivalent to them.

8. The sample size for the training set

This information is not provided. As this is a medical device and not an AI/ML algorithm being developed, the concept of a "training set" in the context of machine learning is not applicable here.

9. How the ground truth for the training set was established

This information is not provided. As explained above, the concept of a "training set" for AI/ML is not relevant to this 510(k) submission for an electrosurgical device.

Ask a specific question about this device